Devices and methods for urine collection

ABSTRACT

A device for collecting urine discharged from a body of a user includes a fluid collection assembly having at least one layer for drawing urine discharged from the body into an interior cavity, an external covering that covers a portion of the at least one layer, and at least one fenestration for receiving urine, wherein the fenestration is a portion of the fluid collection assembly that is uncovered by the external covering. The device further includes a cap enclosing a first end of the assembly, a tube having a first end in fluid communication with the cap, and a shape retaining element configured to conform the assembly to a curved configuration and maintain the curved configuration until the configuration is adjusted. The assembly is configured to be disposed against the body of the user, with the at least one fenestration in operative relation with a urethral opening of the user.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a continuation of U.S. Non-Provisional ApplicationNo. 15/896,325 entitled “Devices and Methods for Urine Collection”,filed on Feb. 14, 2018, which claims priority to (i) U.S. ProvisionalPatent Application No. 62/458,917, filed Feb. 14, 2017, (ii) U.S.Provisional Patent Application No. 62/514,566, filed Jun. 2, 2017, and(iii) U.S. Provisional Patent Application No. 62/556,318, filed on Sep.8, 2017, the contents of each of which are hereby incorporated byreference in their entirety.

BACKGROUND

The present disclosure generally relates to devices, systems, andmethods for collecting urine discharged from the body of a user andcarrying the urine away from the body.

Under various circumstances, a user may have limited or impairedmobility such that ordinary urinary functions and processes are rendereddifficult or even impossible. For example, a person may have impairedmobility due to a disability or may be bedridden due to injury orillness. In another example, a person may be subject to restrictedoccupational conditions under which the person has limited mobility.Finally, urine collection may be needed for monitoring purposes, such asfor monitoring inputs and outputs in a clinical setting (e.g. in theICU, or for other clinical and/or laboratory testing).

Various approaches have been developed to address some of the problemsor circumstances related to impaired or restricted urinary processes.However, the prior approaches suffer from problems or limitations oftheir own. Urinary catheters, for example, can address problems arisingfrom urinary incontinence or limited mobility, but urinary catheters canoften be uncomfortable and can contribute to complications (for example,infections). Bed pans, as another example, are containers occasionallyused for collecting urinary output of a bedridden person (such as apatient at a health care facility), but bed pans can contribute topatient discomfort, spillage, and issues related to sanitation orhygiene.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top perspective view of a urine collection device accordingto an exemplary embodiment.

FIG. 2 is a top view of the device illustrated in FIG. 1.

FIG. 3 is a front view of the device illustrated in FIG. 1.

FIG. 4 is a side view of the device illustrated in FIG. 1.

FIG. 5 is a bottom view of the device illustrated in FIG. 1.

FIG. 6 is a rear view of the device illustrated in FIG. 1.

FIG. 7 is a perspective view of an exploded assembly of the deviceillustrated in FIG. 1.

FIG. 8 depicts an alternative exemplary embodiment of an externalcovering of a urine collection

FIGS. 9A-E depict various exemplary materials and embodiments of anouter collection layer of a urine collection device.

FIG. 10 depicts the placement of the device illustrated in FIG. 1 on thebody of a female patient.

FIGS. 11A-D depict various exemplary embodiments of a tube of a urinecollection device.

FIG. 12A is a side perspective view of a shape retaining element for aurine collection device, according to an exemplary embodiment.

FIG. 12B is a side perspective view of a linking segment of the shaperetaining element illustrated in FIG. 12A, according to an exemplaryembodiment.

FIG. 12C is a sectional view of the linking segment illustrated in FIG.12B, according to an exemplary embodiment.

FIG. 13A is a side perspective view of another shape retaining elementfor a urine collection device, according to an exemplary embodiment.

FIG. 13B is a side perspective view of a linking segment of the shaperetaining element illustrated in FIG. 13A, according to an exemplaryembodiment.

FIG. 13C is a sectional view of the linking segment illustrated in FIG.13B, according to an exemplary embodiment.

FIG. 14 is a sectional view of another shape retaining element for aurine collection device, according to an exemplary embodiment.

FIG. 15 is a sectional view of another shape retaining element for aurine collection device, according to an exemplary embodiment.

FIG. 16A is a side perspective view of a linking segment of a shaperetaining element, according to an exemplary embodiment.

FIG. 16B is a side view of multiple linking segments illustrated in FIG.16A, according to an exemplary embodiment.

FIG. 16C is a side view of a shape retaining element formed frommultiple linking segments illustrated in FIG. 16A, according to anexemplary embodiment.

FIG. 17A is a side perspective view of a linking segment of a shaperetaining element, according to an exemplary embodiment.

FIG. 17B is a side view of a shape retaining element formed frommultiple linking segments illustrated in FIG. 17A, according to anexemplary embodiment.

FIGS. 18A-B are side perspective views of a linking segment of a shaperetaining element, according to an exemplary embodiment.

FIG. 18C is a side view of a shape retaining element formed frommultiple linking segments illustrated in FIGS. 18A-B, according to anexemplary embodiment.

FIG. 18D is a side view of another shape retaining element, according toan exemplary embodiment.

FIG. 19 is an enlarged view of an end of a tube of a urine collectiondevice disposed in a cap, according to an exemplary embodiment.

FIG. 20 is a side view of a curved tube extension of a urine collectiondevice, according to an exemplary embodiment.

FIGS. 21A-B depict another embodiment of a urine collection device.

FIG. 22 depicts various alternative exemplary embodiments of a cap of aurine collection device.

FIGS. 23A-B depict another embodiment of a urine collection device.

FIG. 24 depicts another embodiment of a urine collection device.

FIGS. 25A-C depict various alternative exemplary embodiments of a urinecollection device.

FIG. 26A depicts another embodiment of a urine collection device.

FIG. 26B is a perspective view of an exploded assembly of the deviceillustrated in FIG. 26A.

FIGS. 27A-B depict another embodiment of a urine collection device.

FIG. 27C depicts a sectional view of the device illustrated in FIGS.27A-B, according to an exemplary embodiment.

FIG. 28A-B depict side perspective views of a tube adaptor, according toexemplary embodiments.

FIGS. 29A-B depict various perspective views of a cap of the deviceillustrated in FIGS. 27A-B, according to an exemplary embodiment.

FIGS. 30A-B depict various perspective views of another cap for use witha urine collection device, according to an exemplary embodiment.

FIG. 31 depicts another embodiment of a urine collection device.

FIG. 32 is a schematic diagram of a urine collection system according toan exemplary embodiment.

FIG. 33 is a flow chart depicting a method of using a urine collectiondevice, according to an exemplary embodiment.

FIG. 34 is a flow chart depicting a method of positioning a urinecollection device on a patient, according to an exemplary embodiment.

DETAILED DESCRIPTION

Before turning to the figures, which illustrate the exemplaryembodiments in detail, it should be understood that the presentapplication is not limited to the details or methodology set forth inthe description or illustrated in the figures. It should also beunderstood that the terminology is for the purpose of description onlyand should not be regarded as limiting.

The figures generally show a device for collecting and removing urinethat has been discharged from the body of a user, in particular a femaleuser (e.g., a human female), according to various exemplary embodiments.However, it should be understood that the device described herein may beused with a variety of patients, including male patients with certainanatomical conditions. The device for collecting and removing urinedischarged from a user is configured to hold its placement near thepelvic region on a body of a user such that fluid leakage from thedevice is minimized or eliminated.

Referring to FIGS. 1-7, a urine collection device 10 according to anexemplary embodiment of the present disclosure is shown. Urinecollection device 10 includes an external covering 20 having an openfirst end 22 and an open second end 24. In an exemplary embodiment, theexternal covering 20 is fluid impermeable. A longitudinally extendingfenestration 30 is disposed in a portion of the external covering 20between the open first end 22 and the open second end 24. In somealternative embodiments, there is more than one fenestration in theexternal covering 20. The fenestration 30 is sized and positioned in theexternal covering 20 to be placed in the area of the patient's urethralopening, such that the fenestration 30 allows for fluid flow from anurethral opening of a user's body into a cavity defined by the externalcovering 20 and eventually out to the collection reservoir. In someembodiments, the fenestration 30 extends along an entire longitudinaldirection of the external covering 20, extending an entire distance fromthe open first end 22 to the open second end 24.

The external covering 20 contains and diverts urine that enters throughthe fenestration 30 into a cap 28. From the cap 28, the urine is drawninto a tube 32 for removing the urine from the device 10. The externalcovering 20 is configured to hold the interior components of the urinecollection device 10 together. The external covering 20 can be formedfrom a soft, skin-safe, and hydrophobic material such as silicone,polyurethane, or some other polymeric material in the form of a foam,coating, or a medical grade tape. In some embodiments, an outer surfaceof the external covering 20 is treated with or includes in its materiala texture that grips the skin, which may provide greater stability forthe device 10 to maintain its position.

In the embodiment depicted in FIG. 1, the external covering 20 takes ona curved, hollowed-out, three-dimensional obround shape which completelyenvelops one or more fluid collection layers, except for portions thatare exposed through the fenestration 30.

In other embodiments, the external covering 20 has an alternative shape,such as that depicted in FIG. 8. Referring to FIG. 8, the externalcovering 20 has a first portion 20 a configured to fit over the pubicregion of the body of a user, a second portion 20 b configured to fitthe contours of the perineum of the body of a user, and a third portion20 c configured to cover the coccyx of a user. In one embodiment, theexternal covering 20 has a hydrophobic, closed-cell foam surface havingchannels that include a hydrophilic material. In other embodiments, theexternal covering is manufactured of a soft, hydrophobic material (e.g.,silicone, polyurethane or other polymeric material) forming a foam ormedical-grade tape. In some embodiments, a width of the first portion 20a and a width of the third portion 20 c are approximately equal and awidth of the second portion 20 b is less than the widths of the firstand third portions 20 a and 20 c, respectively.

Referring back to the urine collection device of FIGS. 1-7, andparticularly to the exploded view of FIG. 7, the external covering 20surrounds at least a portion of a fluid collection assembly, comprisingone or more fluid collection layers that evacuate, draw through orabsorb the voided urine. The fluid collection assembly is positionedwithin the external covering 20, with a portion of the fluid collectionassembly exposed at the fenestration 30. In the embodiment shown, thefluid collection assembly includes an outer collection layer 40 and aninner collection core 42. In some embodiments, one or both of theselayers are moisture wicking layers that evacuate the discharged fluidaway from the body (e.g. by wicking or capillary effect). In this way,the layer(s) in direct contact with the anatomy do not feel wet to theuser or cause dampness on the user's skin, improving user comfort.Furthermore, drawing urine away from the urethral opening of the userassists with preventing urine from leaking or flowing into thesurrounding environment (e.g., a bed or chair). In other embodiments,one or more of the fluid collection layers absorb and hold fluid, incombination with or instead of wicking the fluid away.

In some embodiments, the outer collection layer 40 is formed of amaterial having a high absorptive and/or adsorption rate, and a highpermeation rate such that urine can be rapidly wicked and diverted tothe cavity of the device 10. FIGS. 9A-C depict examples of outercollection layers 40 that are fluid permeable (e.g., urine permeable)and have moisture-wicking properties. In one example, the outercollection layer 40 is manufactured of a piece of jersey mesh material,such as that used to make athletic clothing, as shown in FIG. 9A. Theouter collection layer 40 may be made of polyester or a blend ofpolyester and spandex (e.g., a peephole mesh comprising 90% polyesterand 10% spandex and weighing within 5% of 215 g). As a further example,shown in FIG. 9B, the outer collection layer 40 has a corrugated surfacesuch that a surface of the outer collection layer 40 has open-cell foamridges and grooves. This corrugated surface is configured to slow fluidflow at the surface and to provide an increased surface area forpromoting fluid absorption and/or adsorption. As a further example,shown in FIG. 9C, the outer collection layer 40 has a moisture wickingfoam surface manufactured from, for example, a polyurethane foam havingopen cells (e.g., a polyurethane foam having a density of 1.8 lb/ft³ anda pressure to compress 25% of 0.6 psi). In some configurations, thecorrugated layer or foam layer further provides a cushion forsurrounding the tube 32 in the device 10, to limit discomfort to theuser caused by the rigidity of the tube 32.

Referring to FIG. 9D, in some embodiments, the outer collection layer 40has one or more indicators 40 a configured to assist a person (e.g., ahealthcare worker) with optimal positioning of the device inrelationship to the urethral opening of a patient. In some embodiments,the outer collection layer 40 has one or more raised ridges or groovesrunning therethrough, such as ridge 40 b shown in FIG. 9E, creatingraised grooves and ridges configured to slow the flow of fluid at thesurface of the outer collection layer 40, which increases its ability towick fluid and allow more efficient fluid flow through the outercollection layer 40 to the inner collection core 42. Grooves could alsobe sized and configured to wick urine away using capillary action.

Referring back to FIG. 7, an inner collection core 42 is positionedwithin the external covering 20 and inside of the outer collection layer40. In some embodiments, the inner collection core 42 is positionedrelative to the outer collection layer 40 so as to support and maintainthe position of the outer collection layer 40 across the fenestration30. The inner collection core 42 is formed of any suitable material andhas suitable shape that allows for collecting fluid and/or directingfluid flow into an inner cavity of the device 10. The inner collectioncore 42, in this embodiment, is further configured to reduce the contactpressure of the tube 32 on the body of a user. For example, in someembodiments, the inner collection core 42 is a flexible material. Insome embodiments, the inner collection core 42 is manufactured of apolyester filter material (e.g., Nu-Foam formed of a polyester staplefiber of polyethylene terephthalate) that draws the fluid from the outercollection layer 40 and wicks it into the cavity without retaining thefluid.

According to an exemplary embodiment, the tube 32 is manufactured of asemi-rigid material and extends within the external covering 20 betweenthe open first end 22 and the open second end 24. Tube 32 allows avacuum (e.g. a pressure lower than ambient air pressure) to be producedin the cavity of external covering 20 when suction is applied to thetube 32, such that fluid collected within the device 10 is evacuatedfrom device 10 through tube 32. Tube 32 has a first end 33 configured toextend out from the first open end of the external covering 20 and asecond end 34 terminating within the cap 28 (described below). Tube 32is configured to evacuate fluid out from cap 28.

FIG. 10 depicts an exemplary positioning and use of the urine collectiondevice 10 for a female patient. As shown in FIG. 10, the collectiondevice 10 forms to the curvature of the female anatomy, and the lowerend of the collection device 10 is configured to be secured or tuckedbetween the gluteal folds and the perineum. In this way, the collectiondevice 10 is in a position such that when the patient voids, the fluidis absorbed by or drawn through one or more fluid collection layers ofthe collection device 10 (described below), collected into a body of thecollection device 10 and then diverted to a reservoir away from thebody.

The urine collection device 10, according to an exemplary embodiment,includes a shape retaining element. The shape retaining element is abendable element that is configured to conform the fluid collectionassembly to a curved configuration for placement against the body of theuser and maintain the curved configuration of the fluid collectionassembly until the configuration is adjusted. In some embodiments, asdepicted in FIGS. 11A-11D, the tube 32 provides the shape retainingelement and is configured to affect and/or hold the shape of device 10.In one example, shown in FIG. 11A, tube 32 is pre-bent into a shapehaving a curvature 32 a conforming to the anatomical contours of atypical user (e.g., conforming to a majority of female patients) andmaintains the shape during use. In some embodiments, tube 32 ismanufactured of a polyurethane material, such as McMaster PolyurethaneTubing for Water, that maintains a pre-bent shape.

In another example, tube 32 has an adjustable shape (i.e., the curvatureof tube 32 is adjustable). In such an embodiment, tube 32 is flexiblesuch that it can be manipulated by a person (e.g., a healthcare provideror a user) in various directions and is configured to retain its shapefollowing the manipulation. The curvature of device 10 is adjustable,for example, to fit the anatomical curvature of any user. In oneembodiment, shown in FIG. 11B, adjustable tube 32 is surrounded by linksmovable relative to one another, such that a configuration of the tubeis able to be maintained once the tube 32 is bent into a particularshape. In one such embodiment, adjustable tube 32 includes linkingsegments 36 arranged sequentially along a longitudinal direction ofadjustable tube 32. Each of the linking segments 36 has a first portion36 a, a second portion 36 b, and a third portion 36 c. Each portion ishollow or has at least an open portion for passing the tube 32therethrough. The first portion 36 a includes a spherically shaped bodywith an opening therein. The first portion 36 a is connected to a secondhollow portion 36 b having a cylindrical shape and a passagetherethrough for passing the tubing. The second portion 36 b isconnected to third hollow portion 36 c having a semi-spherical shape andforming a hollow cup. The first hollow portion 36 a (the sphericalshape) of one segment is configured to fit within the hollow cup of thethird hollow portion 36 c of an immediately successive segment. In thisway, the linked segments include a series of individual segments linkedto (e.g., by snapping together) a successive individual segment, whereineach segment is able to move relative to the successive segment as thespherical first portion 36 a moves within the hollow cup of the thirdportion 36 c. In yet another example, the adjustable tube 32 is formedby the segments 36, rather than the tube 32 being surrounding thesegments 36. Each one of the segments 36 defines a passage therethrough,whereby the first end of any one segment is coupled to the second end ofan adjoining segment in such a manner as to form a substantiallycontinuous passage for a fluid. In yet another embodiment, the tube 32is coupled to the outside of an adjustable set of linked segments 36that are hollow or solid.

In yet another example, shown in FIG. 11C, tube 32 has an adjustableshape (i.e., the curvature of tube 32 is adjustable). In such anembodiment, tube 32 is flexible such that it can be manipulated by aperson (e.g., a healthcare provider or a user) in various directions andis configured to retain its shape following the manipulation. Thecurvature of device 10 is adjustable to fit the anatomy of any user. Inone such embodiment, adjustable tube 32 includes a one or more wires 32c attached to (e.g., embedded within) a wall of adjustable tube 32. Asone example, the one or more wires 32 c are embedded within an innerwall of adjustable tube 32. The one or more wires 32 c are configured toprovide a flexibility to adjustable tube 32, which allows formanipulation by a person to adjust the shape of adjustable tube 32, andretains the shape once formed. A further example includes one or morebellows associated with the tube 32 that are capable of being shaped andconformed to the user by pressure differentials caused by theapplication of air flow into or out of the device through the tube 32.Air flow could inflate or deflate bellows or segments that would conformthe device 10 to the anatomy of the user.

In a still further example, shown in FIG. 11D, tube 32 has an adjustableshape (i.e., the curvature of tube 32 is adjustable). In such anembodiment, tube 32 is flexible such that it can be manipulated by aperson (e.g., a healthcare provider or a user) in various directions andis configured to retain its shape following the manipulation. Thecurvature of device 10 is adjustable, for example, to fit the anatomy ofany user. In one such embodiment, adjustable tube 32 includes bellows 32d arranged sequentially along a longitudinal direction of tube 32. Thebellows 32 d are configured to allow a person to manipulate the shape ofthe adjustable tube 32 and retain the shape once formed. In someembodiments, the tube itself forms the bellows, and in otherembodiments, the tube is surrounded by and/or coupled to an accessoryproviding the bellows.

Alternatively, in some embodiments, the tube 32 is provided separatelyfrom the adjustable, shape retaining element that allows the device 10to be manipulated into and keep a shape (e.g., be shaped into andmaintain a curved configuration for placement against the body of apatient until the configuration is adjusted). For example, a shaperetaining element is provided in the center of the device 10, and thetube 32 is provided next to the shape retaining element, outside of thedevice 10, and so on. Any of the foregoing examples that allow foradjustability of the device can be provided separate from the tube 32.

FIG. 12A illustrates a shape retaining element 90, according to anexemplary embodiment. In the embodiment shown in FIG. 12A, the shaperetaining element 90 includes a number of linking segments 36. As shownin FIGS. 12B-C, the linking segments 36 are similar to the linkingsegments 36 described above with reference to FIG. 11B, including afirst portion 36 a with a spherically shaped body, a second portion 36 bwith a cylindrical shape, and a third portion 36 c having asemi-spherical shape forming a hollow cup. As such, the linking segments36 are configured to fit together by the first portion 36 a of a firstlinking segment 36 fitting into a third portion 36 c of a second linkingsegment 36 such that the linking segments 36 are movable relative toeach other. Additionally, as further shown in FIGS. 12B-C, the linkingsegments 36 are hollow such that, when the linking segments 36 areconnected together to form the shape retaining element 90, a solid core92 is provided along the center of the shape retaining element 90. Assuch, the linking segments 36 of the shape retaining element 90 are notin fluid communication with each other.

FIG. 13A illustrates another shape retaining element 90, according to anexemplary embodiment. In the embodiment of FIG. 13A, the shape retainingelement 90 again includes a number of linking segments 36. However, asshown in FIGS. 13B-C, the linking segments 36 according to thisembodiment include a cap portion 36 d on top of the first portion 36 a.As such, when the linking segments 36 are connected together to form theshape retaining element 90, the linking segments 36 are each closed offfrom each other such that, for example, the linking segments 36 of theshape retaining element are not in fluid communication with each other.

FIG. 14 illustrates a lengthwise cross-section of another shaperetaining element 90, according to an exemplary embodiment. The shaperetaining element 90 according to FIG. 14 is again formed from a numberof linking segments 36 connected together. These linking segments 36 areprimarily similar to the linking segment 36 shown in FIGS. 12B-C, witheach linking segment 36 having a hollow first portion 36 a, secondportion 36 b, and third portion 36 c without any cap portions. However,the first and last linking segments of the shape retaining element 90are cap linking segments 94 and are configured similarly to the linkingsegment 36 shown in FIGS. 13B-C, with each cap linking segment 94 alsohaving a cap portion 36 d. As such, because the cap linking segments 94include cap portions 36 d, the shape retaining element 90, as a whole,is not in fluid communication with surrounding fluids of the device 10.

FIG. 15 illustrates a lengthwise cross-section of another shaperetaining element 90, according to an exemplary embodiment. The shaperetaining element 90 according to FIG. 15 is similar to the shaperetaining element 90 shown in FIG. 14, being formed from a number ofhollow linking segments 36 and capped by two cap linking segments 94.However, the center of the shape retaining element 90 is also providedwith a solid core 92 extending through the hollow centers of the linkingsegments 36. Alternatively, in some embodiments, the core 92 is replacedwith a tube (e.g., similar to the tube 32) that is thus fully containedwithin the shape retaining element 90. The shape retaining element 90 isprovided with the core 92 or with a tube, for example, to ensure thatthe shape retaining element 90 is subject to “global bends,” or bendsextending smoothly along the extent of the shape retaining element 90,rather than “local bends,” or bends extending only along localized areasof the shape retaining element 90.

FIG. 16A illustrates another linking segment 36 used to form a shaperetaining element, according to an exemplary embodiment. As shown inFIG. 16A, the linking segment 36 includes a first portion 36 a with ahollow spherically shaped body, a second portion 36 b with a hollowcylindrical shape, and a third portion 36 c having a semi-sphericalshape forming a hollow cup. Additionally, third portion 36 c is formedwith a number of slots 36 e spaced around the linking segment 36. Assuch, when linking segments 36 according to FIG. 16A are connectedtogether, as shown in FIG. 16B, the linking segments 36 do not allowfluid flow (e.g., urine or air flow created by suction) between eachother due to the slots 36 e. In this way, the linking segments 36 areconnected together to form a shape retaining element 90, as shown inFIG. 16C, that does not provide for fluid communication along thelengthwise extent of the shape retaining element 90.

FIG. 17A illustrates another linking segment 36 used to form a shaperetaining element, according to an exemplary embodiment. As shown inFIG. 17A, the linking segment 36 includes a first portion 36 a with ahollow spherically shaped body, a second portion 36 b with a hollowcylindrical shape, and a third portion 36 c having a semi-sphericalshape forming a hollow cup. Additionally, the second portion 36 b isprovided with one or more holes 36 f As such, when the linking segments36 according to FIG. 17A are connected together to form a shaperetaining element 90, as shown in FIG. 17B, the linking segments 36 donot allow fluid flow (e.g., urine or air flow created by suction)between each other due to the holes 36 f.

FIGS. 18A-B illustrate another linking segment 36 used to form a shaperetaining element, according to an exemplary embodiment. As shown inFIGS. 18A-B, the linking segment 36 includes a first portion 36 a with ahollow spherically shaped body, a second portion 36 b with a hollowcylindrical shape, and a third portion 36 c having a semi-sphericalshape forming a hollow cup. However, the third portion 36 c is providedwith two slots 36 e forming a member 36 g between them. As such, oneside of the linking segment forms a flange while the other side islargely open. Due to this, the linking segments 36 according to FIGS.18A-B are connected together to form a shape retaining element 90 thatallows for a one-way bend because the flanged side of the linkingelements 36 blocks a backwards bend. Moreover, the members 36 gfacilitate a global bend along the shape retaining element 90 byallowing for a uniform radius of curvature. In some embodiments, theends of the shape retaining element 90 are closed off (e.g., by beingprovided with linking segments including cap portions 36 d).Additionally, as shown in FIG. 18D, the linking segments 36 are providedwith a larger number of slots 36 e creating a larger number of members36 g such that the shape retaining element 90 is bendable in more thanone direction.

It should be understood that the shape retaining elements 90 illustratedin FIGS. 12-18 are exemplary and that other shape retaining elements 90may instead be used with a urine collection device. For example, aflexible tube or solid element may be impregnated with or be wrapped ina coiled foil or mesh made up of a thin flexible metal to form a shaperetaining element 90, with the coiled foil or mesh configured to beflexible and hold the shape of the element 90 when bent. As anotherexample, the coiled foil or mesh is used by itself as a shape retainingelement 90. The flexible mesh or element may be molded into the flexibletube or flexible solid element such as by co-extrusion.

In some embodiments, the device 10 is otherwise configured to conform tothe curvature of the user and to maintain its shape while in use. In oneexample, the device 10 or the tube 32 may be constructed with a bias toa curved configuration. The bias is provided, for example, by a spring,or by one or more memory shaped wires or supports associated with thedevice 10 or the tube 32. In this way, the device 10 is naturallyinclined to a curved position, optionally, a tight curvature. Forpositioning on the user, the device 10 can be “opened” or otherwisestraightened, and then released when placed in a proper location,thereby held tightly against the user's body in a conformedconfiguration by the biasing force.

In another example, a device is individually configured to a user toprovide a custom fit. This is achieved, for example, through curation ofa polymer after setting the device to a proper fit for the user. As anexample, a molded plastic part is warmed such that the proper shape canbe set as it cools in a proper position on the user. In another example,an external light source assists with curing the device to have a customfit.

In yet another example, the application of suction can also be used toshape and conform the device to the user by creating vacuum. Forexample, once the suction is turned on, the reduced pressure createdwithin the device body can draw in or otherwise act upon the body tomove it to a curved configuration that corresponds with the user'sanatomy. In some embodiments, the device includes one or more bellowscapable of being shaped and conformed to the user by pressuredifferentials caused by air flow into or out of the bellows. Air flowcould inflate or deflate bellows or segments that would conform thedevice 10 to the anatomy of the user. Similarly, in other embodiments,the reduced pressure created in the cavity of the device holds andmaintains the unit in place, in addition to being useful for conformingto the wearer's body. In this way, the use of suction may draw in orotherwise engage the device 10 with the user's body.

As shown in FIG. 19, according to an exemplary embodiment, the secondend 34 of the tube 32 has a slit, aperture, or cut out portion, such asaperture 34 a, to better allow air flow into the cap 28 while thesuction is applied. The space created between the second end 34 of thetube 32 and the cap 28 by the slit, aperture, or cut prevents the secondend 34 from being suctioned to and forming an air tight seal against thecap 28, which would prevent the flow of the collected urine through thetube 32.

In some embodiments, the tube 32 extends all the way from the device 10to a fluid collection reservoir 204, as depicted in FIG. 32 anddescribed in further detail below. However, in other embodiments, tube32 terminates at the first end 33 of the tube, and is coupled at thefirst end 33 to a curved tube extension 35, as shown in FIG. 20. In suchembodiments, the curved tube extension 35 is an intermediate elementbetween the tube 32 and a discharge tube line 102 that is coupledbetween the device 10 and the collection reservoir 204 as shown in FIG.32. The curved tube extension 35 is used to modify the direction atwhich the tube 32 and discharge tube line 202 extend. It is advantageousthat the tubing be directed away from the user's body, such as off theside of the bed, rather than extending up towards the head of the user.This prevents the tubing from accidental pulling, risking leakage bypulling the device out of its placement in relation to the urethralopening of a user, or being an irritation to the user. Accordingly, thecurved tube extension 35 directs the tubing immediately off to the sideof the user, without causing a bend and possible kink in the tube whichmay occur when attempting to bend a straight tube. In some embodiments,the first end 33 of the tube 32 is formed to have a curvature making thebend, thereby eliminating the need for a separate curved tube extension35 element.

In some embodiments, the curved tube extension 35 is capable of rotationrelative to the first end 33 of the tube 32 so a user or another persondisposing the device on the body of a user is able to direct the tubingto extend in any direction, for example, in a preferred directiondepending on where the collection reservoir is placed relative to theuser.

Referring again to FIGS. 1-7, the urine collection device 10 furtherincludes cap 28 at the open second end 24 of the external covering 20.Cap 28 is coupled to the second open end of the external covering 20,and a water-tight seal is formed therebetween. Cap 28 acts as areservoir for diverted fluid which has been collected by the device 10from the urethral opening of a user. As described above, the second end34 of the tube is disposed in the cap 28, such that fluid is drawnthrough the tube 32 from within the cap 28. In some embodiments, cap 28has an outer surface configured to secure the device in positionrelative to the user, i.e. between the gluteal folds within theperineum. In some embodiments, the cap 28 is sized and configured tohold together the ends of the tube 32, the inner collection core 42, andthe outer collection layer 40 such that the urine collected and drawnthrough the inner collection core 42 and outer collection layer 40 isdiverted (i.e., due to gravity or a reduced pressure created in the capby suction through the tube 32) and collected in the cap 28. The cap 28is configured to collect and hold urine that has been expelled from theurethral opening of a user for a temporary period of time until theurine is removed from the device through the tube 32. In someembodiments, the cap 28 is any suitable shape and/or size capable ofcollecting fluid removed from the urethral opening of a user and passedthrough the outer collection layer 40 of the device 10.

Cap 28 is attached to device 10 by any suitable means. In one example,cap 28 is attached (e.g., secured, connected, etc.) to the open secondend 24 of device 10 by tape. In a further example, as shown in FIG. 21B,cap 28 is attached or connected to the open second end 24 by shrinkwrapping 65 wound around cap 28 and the open second end 24, thussecuring cap 28 to the open second end 24 of device 10.

In some embodiments, cap 28 has a cup-like shape. In some embodiments,cap 28 is manufactured of a material that is biocompatible (e.g., willnot induce an immune response in a user), soft so as not cause pressurepoints, and/or flexible. Cup-shaped cap 28 is, for example, formed ofsilicone rubber or other polymeric material which may be certified asUSP Class-IV.

In some embodiments, cap 28 has a wedge shape, as shown in the variousembodiments illustrated in FIG. 22. A wedged-shaped cap has a cupportion with a tapered surface configured to fit into the gluteal foldsand perineum of the body of a user such that cap 28 stays in position onthe body of a user.

In some embodiments, an external portion of the cap 28 has an adhesiveportion. The adhesive portion is configured to secure device 10 to thebody of a user between the gluteal folds such that device 10 stays inposition on the body of a user. In some embodiments, the adhesiveportion is made of any suitable biocompatible material (e.g., does notinduce an immune response in a user). For example, the adhesive portionis made of a silicone based adhesive with certifications forcytotoxicity, skin irritation, and skin sensitization. The adhesiveportion may be an adhesive coating or material applied to the exteriorof the cap 28, or may be a piece of adhesive material adhered to theexterior of the cap 28.

Referring again to FIGS. 1-7, the urine collection device 10 includes ananchor 50 connected to the device 10 at or adjacent to the open firstend 22 of the external covering 20. The anchor 50 is configured tosecure the device 10 in position to collect and transport urine voidedby a user. The shape of the anchor 50 is configured to conform to thesurface area of the skin of the pelvic region of the user withoutpulling or pinching the skin or bunching up in ways that would causediscomfort. Anchor 50 has any suitable shape and structure to secure thedevice to the body of a user and to remain secured despite a wearer'smotion, moisture accumulation on the body, or passage of time. In theembodiment shown in FIGS. 1-7, anchor 50 includes a center portionconfigured to attach to the body of a user between the pubic region andthe umbilical region, with two wing portions extending outward towardsthe lateral regions of the body. In another embodiment, as shown inFIGS. 23A-B, anchor 50 has a shape extending in a more lateral mannerrelative to the device, having a narrower central portion 51 a and widerwing portions 51 b on each side of the central portion 51 a. In thisembodiment, the anchor 50 is particularly suited for the specificpatient, depending on age, weight, body composition, or other factorsthat may dictate the size of the anchor 50. For example, the laterallyextending anchor 50 in FIGS. 23A-B may provided in a first size (up toapproximately 5 centimeters in length), a second size (betweenapproximately 5 centimeters and 15 centimeters in length), a third size(between approximately 15 centimeters and 25 centimeters in length),and/or a fourth size (between approximately 25 centimeters and 40centimeters in length). Similarly, the laterally extending anchor 50 inFIG. 23A-B may be provided having different widths, for example a firstsize (up to approximately 2 centimeters wide), a second size (betweenapproximately 2 centimeters and 6 centimeters wide), a third size(between approximately 6 centimeters and 10 centimeters wide, and/or afourth size (between approximately 10 centimeters and 20 centimeterswide). A health care professional may have a variety of anchors fromwhich to choose from in the above ranges, and may select the anchor mostappropriate for the user.

Alternatively, the anchor 50 includes wider portions that are notconnected by a central portion. As an illustration, FIG. 24 depicts anembodiment of a urine collection device 10 designed such that a body ofthe device 10 bifurcates into two ends 22 (e.g., into a “Y” shape), andeach end is provided with a wider portion 51 b. Accordingly, the twowider portions 51 b move independently from each other. Such a designmay allow for a more customized fit to a patient, as the bifurcationsand separate portions 51 b allow the device 10 to be more flexiblyfitted to a patient in placing the device 10 due to more degrees offreedom.

In some embodiments, anchor 50 includes an external film for covering anadhesive layer, which is configured to be easily removable using a tabor tabs that are part of the external film or are connected to theexternal film. In some embodiments, anchor 50 further includes a tabconfigured to allow a person (e.g., a healthcare provider) to remove theanchor 50 from the body of a user without causing discomfort or harm tothe body of a user when attempting to remove. The anchor 50 and adhesivelayer may be of such a configuration to avoid portions of the body thatare covered with hair, since adhering the anchor to these portions ofthe body could result in uncomfortable pulling or removing hair uponremoval of the anchor 50. According to some embodiments, only a portionof the anchor 50 includes adhesive for securing to the user. Forexample, only the outer edges of the anchor 50 include an adhesive area,or only the inner areas not extending to the outer edges include theadhesive area. In yet another example, only certain portions or plotswithin the anchor 50 area include adhesive. Various configurations andplacement of adhesive may be used to best accommodate securing theanchor 50 and the device 10 to the user's body without over-use ofadhesive.

According to some embodiments, the anchor 50 is constructed havingseparate and removable portions, such that the anchor 50 has a variableshape and/or dimension. For example, the anchor 50 has perforations suchthat certain distal portions or entire areas of the anchor 50 can beremoved to better fit the body of the user. The anchor 50 is,alternatively, adjustable to allow for varying the dimension of theanchor.

The anchor 50 may be any suitable biocompatible material which may beused with the skin of a user, such as human skin. In some embodiments,anchor 50 is stretchable. In some embodiments, anchor 50 is manufacturedof a urethane or other polymeric material film adhesive having a foambacking configured to provide strength, stability, and support. Forexample, the adhesive layer is silicone based with a minimal amount ofacrylic or none at all. In some embodiments, the adhesive is a DowCorning Soft Skin Adhesive MG 7-9900. In some embodiments, the foambacking provides a layer to prevent the tube 32 from rubbing against theskin adjacent to the pelvic region of the user.

Anchor 50 is attached to device 10 by any suitable means. In oneexample, anchor 50 is attached (e.g., secured, connected, etc.) to theopen first end 22 of device 10 by tape that secures anchor 50 to openfirst end 22. In a further example, as shown in FIG. 21A, anchor 50 isattached or connected to the open first end 22 by shrink wrapping 60wound around an end of anchor 50 and the open first end 22, thussecuring anchor 50 to the open first end 22 of device 10.

In other embodiments, the anchor portion is provided for use inassociation with the device 10, but that is not directly coupled to thedevice 10. For example, an adhesive portion is provided to secure thetube 32 or discharge tube line 102 to the user, but not necessarily tosecure the device 10 itself to the user. In another embodiment, ananchor 50 as described above may be provided with the device 10, butthat is not directly coupled to the device 10 during production. In yetanother embodiment, the device does not include anchor 50 at all, and isable to be fixed relative to the body by another fixation mechanismexemplified below.

For example, in addition to or instead of anchor 50, the device 10includes another fixation mechanism such as an elastic band or strap. Inthis example, the band or strap is coupled to the device 10 andconfigured to wrap around the user's waist or leg, for example.Similarly, the device 10 may be configured to be used in associationwith a wearable garment, such as a brief that is used to hold the device10 in position relative to the user's body. In yet another example, aprojection extends from the device 10 that is configured to be insertedinto the vagina of the user to maintain the positioning of the device10.

As mentioned previously, in some embodiments, the cap 28 also providesfor fixation of the device relative to the body. Referring again to FIG.22, the various shapes of the cap 28 provide for associating the devicewith the body in a more secure relationship. For example, thewedge-shaped cap 28 shown in the embodiment of FIGS. 23A-B fits with theanatomy, such as in the gluteal folds, the gluteal cleft, or theperineum. In this way, the device 10 is more securely fixed relative tothe body. In some embodiments, the cap 28 also has adhesive on the outersurface to increase the fixation even further. In some embodiments, thedevice 10 includes an additional adhesive area, either along the sidesor the distal end of device 10 to assist with fixation. The additionaladhesive area may be a second anchor configured for attachment to theuser's body. The additional adhesive area may also be located along thesides of the device 10. The additional adhesive area may be used insteadof anchor 50 and/or cap 28 adhesive, or may be used in combination withone or both.

Finally, as mentioned previously, the application of the suction may beused to hold the device 10 securely in place on the user's body. Forexample, the suction may be used to form the device 10 in a curvaturecorresponding to the user's anatomy in such a tight way that theengagement of the device 10 with the body is secure. In another example,the pressure differential between the inside of the device 10 and theambient air surrounding the user causes the device 10 to be drawn intowards, and in direct contact with the skin of the user, which may bemaintained securely until the suction creating the vacuum condition isinactivated.

In some embodiments, the device 10 also includes a wedge formed at ornear open first end 22 of device 10 in an area intended to be positionednear the urethral opening of the patient. The wedge is configured toseparate the labia majora and labia minora of the body of a user tomaintain and direct fluid flow directly to the device 10 surface fromthe urethral opening. In some embodiments, shown for example in FIG.25A, the wedge includes an orifice with a cylindrical shapedprotuberance configured to fit over the urethra of the body of a usersuch that fluid flow is diverted from urethral opening through aninternal cavity of device 10 and into cap 28. In some embodiments, shownfor example in FIG. 25B, the wedge is manufactured of a fabric andconfigured to be disposed over the urethral opening of the body of auser and collect fluid voided from the urethral opening of the user. Inyet another embodiment, shown for example in FIG. 25C, a urethral funnel80 is disposed over the urethra of a user. The urethral funnel includesa backsplash that redirects voided fluid to a tube configured toevacuate fluid at a recess within the tube.

According to some embodiments, such as the embodiment of FIGS. 21A-B,23A-B, and 24, external covering 20 does not form a cylindrical body asshown in the embodiments of FIGS. 1-7, and is alternatively a fluidimpermeable backing formed by a sheet of fluid impermeable materialwrapped around an underside of the fluid collection assembly (i.e.,around a portion of the inner collection core 42 and outer collectionlayer 40). The fluid impermeable material may be enclosed around thefluid collection assembly on each end by tape or by shrink wrap materialas described above. In this embodiment, a portion of the externalcovering 20 is attached (e.g., secured, connected, etc.) to outercollection layer 40 by any suitable means. For example, as shown inFIGS. 21A-B, 23A-B, and 24, edges of the external covering 20 aresecured to the outer collection layer 40. In one specific example, edgesof external covering 20 are sewn to the outer collection layer 40 alongline 46. In another specific example, edges of external covering 20 areultrasonically welded to the outer collection layer 40 along line 46.Accordingly, in such embodiments, the fenestration for receiving urineincludes the top portion of the device 10 not covered by the externalcovering 20 (e.g., the top half of the device 10 shown in FIGS. 23A-B).

FIG. 26A illustrates another embodiment of the urine collection device10 with a fluid impermeable backing. Additionally, the device 10 shownin FIG. 26A is flatter and wider than the device 10 shown in FIGS.23A-B. As illustrated in an exploded view of the device 10 shown in FIG.26B, the device 10 includes similar components in the fluid collectionassembly of the device 10 as those shown in FIGS. 1-7. Accordingly, thedevice 10 shown in FIGS. 26A-B includes a collection layer 40 (e.g.,created from a permeable fabric) provided on the top side of the device10, an external covering 20 configured as a fluid impermeable backing,and a cap 28 (e.g., with a smooth bottom for a close fit to thepatient's anatomy). The inner collection core 42 is provided as a firstlayer 42 a of batting that surrounds a second layer 42 b of batting,which in turn surrounds the tube 32. The device 10 also includes asuction tubing adaptor 70 that allows the tube 32 in the device 10 to befitted to a separate length of external tubing, such as suction tubing,or another device, such as a suction device.

Further, the fluid impermeable backing includes a shape retainingelement 90 provided in the form of a core integrated into the backing.In various embodiments, the core is a metal core (e.g. aluminum, lead,copper, stainless steel, or any type of soft metal) or a plastic core.For example, in one embodiment, the core of the shape retaining element90 includes one or more shape memory wires configured to provide a biasto the device 10. As shown, the device 10 includes one shape retainingelement 90, though in other embodiments the device 10 includes more thanone shape retaining element 90 (e.g., two or more). The shape retainingelement 90 is incorporated into the external covering 20, for example,by wrapping or encasing the shape retaining element. In somearrangements, the shape retaining element 90 is integrated into theexternal covering 20 by encasing the shape retaining element 90 in foamof the external covering 20. In other arrangements, the shape retainingelement 90 is insulated or heat shrink dipped and incorporated into theexternal covering 20. It should be understood, however, that the device10 may be formed into a different shape and/or include a different shaperetaining element 90. For example, the device 10 may be formed into aY-shape, similar to the device 10 shown in FIG. 24, with a similarY-shaped shape retaining element 90 formed into the external covering20.

FIGS. 27A-B illustrate another embodiment of the urine collection device10 with a fluid impermeable backing. As shown in FIG. 27A, the device 10includes a shape retaining element 90 formed from hollow linkingelements 36 provided with core 92 (e.g., in the form of a tube, asillustrated in FIG. 27A, or as a solid core). As illustrated in FIG.27C, the shape retaining element 90 is inserted into a center of thedevice 10 to allow the device 10 to be shaped and maintain its shape, asdescribed above with reference to FIGS. 12-18. The core 92 is configuredto support the device 10 rather than facilitate the removal of fluidfrom the device 10. It should further be understood that the device 10may be provided with any of the shape retaining elements 90 describedabove with reference to FIGS. 12-18.

Moreover, the device 10 shown in FIGS. 27A-C includes an external tube32 that fits into and extends out of the cap 28 to divert fluid awayfrom the device 10. The external tube 32 replaces the internal tube thatfits into the body of the device 10 as shown, for example, in FIGS. 1-7.As illustrated in FIG. 27C, fluid flows into the device 10 via the outercollection layer 40, is collected in the cap 28, and is subsequentlydiverted from the device 10 via the external tube 32 connected to thecap 28. The external tube 32 has numerous degrees of freedom, allowingthe tube 32 to be positioned away from the patient as needed. In someembodiments, a hook 100 is provided on a top surface of the device 10into which the external tube 32 is tucked or slid (e.g., to ensure thatthe external tube 32 is not accidentally pulled out of the cap 28 andthe device 10). Alternatively, in some embodiments, the tube 32 isprovided in the impermeable layer of the external covering 20 (e.g., inaddition to, or instead of, a shape retaining element 90 provided in theimpermeable layer of the external covering 20 similar to the element 90shown in FIGS. 26A-B).

Further, the second end 34 of the external tube 32 is provided with atubing adaptor 70 such that the tube 32 is connectable to a secondlength of tube (e.g., suction tubing) leading away from the patient orto another device (e.g., a suction device). FIGS. 28A-B illustrateexemplary embodiments of the adaptor 70. FIG. 28A illustrates a maleadaptor 70, and FIG. 28B illustrates a female adaptor 70. The maleadaptor 70 includes step tapering, for example, to help ensure that theadaptor 70 fits snugly within the second tube or device. By contrast,the female adaptor 70 includes an opening into which the second lengthof tube may be inserted and may also include step tapering within theopening. However, the adaptors 70 shown in FIGS. 28A-B are meant to beexemplary. As such, in other embodiments, the adaptor 70 is replacedwith a different connector, such as a first side of a snap that fitsinto a corresponding second side of a snap on a suction tube/device, ora detent piece that fits inside of a suction tube/device. Additionally,in some embodiments, the adaptor includes or is connected to, or theexternal tube 32 is otherwise provided with, a diverter valve thatallows a user to change the flow of fluid to a different attachmentand/or a stop valve that allows a user to turn off the flow of fluidfrom the device 10. The diverter valve would allow for the flow of urineto a separate collection receptacle such as that meant for testingsamples of the collected urine.

As discussed above, the first end 33 of the external tube 32 is insertedinto the cap 28 to couple the tube 32 to the device 10. FIGS. 29A-Billustrate the cap 28, according to an exemplary embodiment. As shown inFIGS. 29A-B, the cap 28 has a smooth, elongated, wedge shape with curvedsides configured to fit patient anatomy. The cap 28 includes an open end29 configured to fit onto the open second end 24 of the device 10. Theopen end 29 includes a flange 110, and the inside surface of the cap 28is provided with ribbing 112 to help ensure a snug fit between the cap28 and the second end 24 of the device 10. The cap 28 also includes aport 31 into which the first end 33 of the external tube 32 is insertedto couple the tube 32 to the cap 28, for example, by threading the firstend 33 into the port 31. As shown in FIGS. 27A-C, the port 31 extendsnear the open end 29 at an angle from the side of the cap 28. However,it should be understood that in other embodiments, the port 31 isprovided anywhere on the cap 28 or, in some embodiments, elsewhere onthe device 10. Alternatively, the cap 28 does not include a port 31 andmay instead include a tubing adaptor 70 that connects directly toexternal suction tubing or an external suction device. In someembodiments, the cap 28 includes elements in addition to those depictedin FIGS. 29A-B, such as a relief valve or a holding element similar tothe holding element described below with reference to FIGS. 30A-B.

In some embodiments, the first end 33 of the device 10 is also providedwith a cap, such as the top cap 120 illustrated in FIGS. 30A-B. Asshown, the top cap 120 includes a connecting end 122 that extends out toform a tab 124, which is configured to secure the device 10 to thepatient (e.g., by conforming to the patient's anatomy). The connectingend 122 includes a rim 126 configured to fit around the first end 22 ofthe device 10, as well as a holding feature 128 configured to hold aninside solid or tubular flexible element, such as a shape retainingelement, through an annular fit. The connecting end 122 is also providedwith a hook 130, which may be similar to the hook 100 and hold anexternal tube 32 in place during use of the device 10. The connectingend 122 also includes holes 132 that extend through the width of theconnecting end 122 and serve as vent holes or valves to prevent skinsuction (e.g., when the device 10 is connected to a suction element inorder to vacate the device 10 of fluid).

FIG. 31 illustrates another embodiment of a urine collection device 10with the external covering 20 designed as a fluid impermeable backing.In the embodiment of FIG. 31, the external covering 20 is formed from anumber of backing tubes 20 d provided side-by-side to form a fluidimpermeable surface. The backing tubes 20 d are, for example, extrudedtogether, adhered together, stitched together, or otherwise connectedtogether to form the fluid impermeable surface of the external covering20. Additionally, at least one of the backing tubes 20 d is providedwith the a tube 32 fitted within the backing tube 20 d to allow for thedirection of fluid into the cap 28 (not shown in FIG. 30) and out of thedevice 10.

The device 10 may be made of various materials and components asdescribed above. Any of the materials used for the components of device10 described above may be an antimicrobial material or fabric, or havean antimicrobial treatment applied thereto.

Referring now to FIG. 32, a system 200 for collecting urine that isdischarged from the body of a user and carrying the collected urine awayfrom the body is shown. The system includes the urine collection device10 for collecting urine that is discharged from the body of a user. Thesystem further includes discharge tube line 202 coupled to the tube 32of the collection device 10 and disposed between the tube 32 andexternal collection reservoir 204. The system further includes an airpump or vacuum source 210 for providing suction through the tube 32,connected to the external receptacle via a vacuum line 212. In someembodiments, the discharge tube line 102 and the vacuum line 212 bothcomprise a flexible tubing (e.g., flexible plastic tubing). In someembodiments, the external reservoir 204 is a sealed container. In someembodiments, the external reservoir 204 is disposable. In someembodiments, the external collection reservoir 204 is configured to besterilized after a use and reused. In some embodiments, tube 32 of thecollection device 10 and the discharge tube line 202 are manufactured asa single piece of tubing.

The vacuum source 210 has a sufficiently high vacuum strength such thatrapid air and liquid aspiration is maintained over at least a portion ofthe permeable membrane. In some embodiments, the vacuum source 210 canbe a pump that is commercially available and configured to runcontinuously or sporadically. In some embodiments, the vacuum source 210is a wall vacuum already integrated into the room of a medical facility.For example, the vacuum line 212 is directly connected to a vacuumregulator in the room.

FIG. 33 is a flowchart illustrating an exemplary method 300 for using adevice for collecting and evacuating urine that is discharged from thebody of a patient. The device used in method 300 is the same or similarin structure and/or function to any of the devices disclosed anddescribed with reference to FIGS. 1-31.

In step 301, the vacuum line 212 is coupled to the vacuum source 210. Instep 302, the discharge tube line 202 is coupled to the fluid collectionreservoir 204. In step 303, the urine collection device, such as urinecollection device 10 is coupled to the patient. FIG. 34 is a flowchartdepicting the substeps involved in step 303 for positioning the deviceon the patient.

In step 304, the free end of the discharge tube line 202 is coupled tothe device 10, via the first end 33 of the tube 32. At this time, itshould be confirmed that all tubing is free of obstacles. In someembodiments, the discharge tube line 202 is coupled to a curved tubeextension 35. In step 305, suction is activated by way of the vacuumsource such that urine voided from the patient can be collected andremoved from the patient. In some embodiments, there could be continuoussuction. In some uses, the suction remains activated for an extendedperiod of time such that it is always effective for collecting andremoving voided urine. In other uses, the suction is selectivelyactivated only when needed, such as when the patient has voided.

In step 306, the device is removed from the body of a patient. Followingstep 306, the method may be repeated using a second, clean device forcollecting and removing urine from the body of a patient. The device mayneed to be replaced periodically, such as every 12 or 24 hours, andshould be disposed of according to hospital protocol. The anchor 50, ifit is a separate piece, may be replaced after a longer period of time,such as 8, 12, 24, or 36 hours or longer. In some situations, the devicemay need to be replaced more or less often depending on several factors,including maintenance of proper positioning, leakage, volume of urinecollected, and any other factors which may require sooner replacement ormay allow the device to be used for a greater length of time.

At any time during the above method, a user or a caregiver may re-assessand correct the fit and positioning of the device, such as immediatelyafter placement, after initial activation of the suction, after anextended period time, after patient repositioning, etc.

FIG. 34 is a flowchart depicted the sub-steps of positioning the devicein contact with the patient in step 303. Prior to positioning thedevice, the caregiver may perform the proper hand hygiene and perinealcare per hospital protocol. In step 401, the patient's legs areseparated. In step 402, the patient's labia is separated using one hand.In step 403, using the other hand, the device is held vertically withcap 28 facing-downward and the fenestration 30 facing the patient'slabia. Prior to this step, the caregiver may need to remove the device10 from device packaging. In step 404, the edge of the device is alignedwith the perineum and outer collection layer 40 is positioned againstthe urethral opening. In step 405, the cap 28 is secured between thepatient's gluteal folds. In some embodiments where there is adhesive onthe cap 28, the adhesive is secured between the patient's gluteal folds.In step 406, the labia is released.

In step 407, the anchor 50 is bent toward the pubic region. In thisstep, the caregiver may need to hold the device in this curvature untilthe anchor 50 is secured, or in the embodiment with the adjustable tube,the device will maintain this curvature after it is adjusted. In somecases, the device 10 already has the proper curvature such that nobending or adjustment is necessary. In step 408, the liner covering theadhesive is removed and the anchor 50 is smoothed over the patient'ssuprapubic region. Once the device is positioned and the properplacement is confirmed, the patient's legs should be closed to furthersecure the device in place.

Accordingly, when properly placed, the device should be positioned suchthat the at least one fenestration 30 of the device is in operativerelation with a urethral opening of the patient such that urinedischarged from the urethral opening is received by the device (e.g.,the fluid collection assembly of the device, as described above) at theat least one fenestration 30. For example, the device should bepositioned in a vertical orientation such that the at least onefenestration 30 is in operative relation with a urethral opening of afemale patient. The urine is then directed into the cap 28, as describedabove, and evacuated from the device via the tube (e.g., via an internaltube 32 running inside the length of the device from the cap 28 to theopen second end 24 or by an external tube 32 coupled to the cap 28). Itshould further be understood that a process similar to step 303 may beused to position the device with respect to a male patient but insteadof separating and placing the device with respect to the patient'slabia, the device is positioned, for example, in a cup-shapedconfiguration with at least one fenestration in operative relation witha urethral opening of a male user.

As utilized herein, the terms “approximately,” “about,” “substantially,”and similar terms are intended to have a broad meaning in harmony withthe common and accepted usage by those of ordinary skill in the art towhich the subject matter of the present disclosure pertains. It shouldbe understood by those of skill in the art who review the presentdisclosure that these terms are intended to allow a description ofcertain features described and claimed without restricting the scope ofthese features to the precise numerical ranges provided. Accordingly,these terms should be interpreted as indicating that insubstantial orinconsequential modifications or alterations of the subject matterdescribed and claimed are considered to be within the scope of thepresent disclosure as recited in the appended claims.

The terms “coupled,” “connected,” and the like as used herein mean thejoining of two members directly or indirectly to one another. Suchjoining may be stationary (e.g., permanent) or moveable (e.g., removableor releasable). Such joining may be achieved with the two members or thetwo members and any additional intermediate members being integrallyformed as a single unitary body with one another or with the two membersor the two members and any additional intermediate members beingattached to one another.

References herein to the position of elements (e.g., “top,” “bottom,”“above,” “below,” etc.) are merely used to describe the orientation ofvarious elements in the FIGURES. It should be noted that the orientationof various elements may differ according to other exemplary embodiments,and that such variations are intended to be encompassed by the presentdisclosure.

It is to be understood that although the present disclosure has beendescribed with regard to embodiments thereof, those skilled in the artwill readily appreciate that many modifications are possible (e.g.,variations in sizes, structures, shapes and proportions of the variouselements, mounting arrangements, use of materials, orientations, etc.)without materially departing from the novel teachings and advantages ofthe subject matter described herein. For example, the order or sequenceof any process or method steps may be varied or re-sequenced accordingto alternative embodiments. Other substitutions, modifications, changes,and omissions may also be made in the design, operating conditions, andarrangement of the various exemplary embodiments without departing fromthe scope of the present disclosure.

With respect to the use of substantially any plural and/or singularterms herein, it should be understood that the plural to the singularand/or the singular to the plural may be translated as is appropriate tothe context and/or application. The various singular/plural permutationsmay be expressly set forth herein for the sake of clarity.

What is claimed is:
 1. A device for collecting urine discharged from abody of a user, comprising: a fluid collection assembly having a firstend, the fluid collection assembly comprising at least one layer fordrawing urine discharged from the body of the user into an interiorcavity of the device; an external covering that covers a portion of thefluid collection assembly; at least one fenestration for receivingurine, wherein the at least one fenestration is a portion of the fluidcollection assembly that is uncovered by the external covering; a tubehaving a first end in fluid communication with the first end of thefluid collection assembly; a wedge-shaped structure at the first end ofthe fluid collection assembly, wherein the wedge-shaped structure has atapered surface that is configured to fit into gluteal folds and aperineum of the body of the user, wherein the tapered surface defines anedge at the first end of the fluid collection assembly, wherein the edgehas a length and a width, wherein the length is greater than the width,wherein the wedge-shaped structure has a first end and a second end,wherein the second end of the wedge-shaped structure is coupled to thefirst end of the fluid collection assembly, and wherein the first end ofthe wedge-shaped structure is closed; and an anchor comprising anadhesive layer and extending beyond at least two sides of fluidcollection assembly, wherein the anchor is configured to secure thefluid collection assembly such that the fluid collection assembly isdisposed against the body of the user, with the at least onefenestration in operative relation with a urethral opening of the usersuch that urine discharged from the urethral opening is received by thefluid collection assembly at the at least one fenestration, and thenevacuated through the tube.
 2. The device according to claim 1, whereinthe wedge-shaped structure comprises a cap enclosing the first end ofthe fluid collection assembly.
 3. The device according to claim 2,wherein the tube is coupled to and extends from the cap and is externalto the fluid collection assembly.
 4. The device according to claim 1,wherein a second end of the tube has at least one feature selected froma group consisting of: a slit, an aperture, and a cut out portion. 5.The device according to claim 1, further comprising a curved tubeextension positioned between the first end of the tube and the fluidcollection assembly.
 6. The device according to claim 5, wherein thecurved tube extension is rotatable relative to the first end of thetube.
 7. The device according to claim 1, wherein an outer surface ofthe wedge-shaped structure includes an adhesive.
 8. The device accordingto claim 1, wherein the fluid collection assembly comprises an outercollection layer and an inner collection core positioned within theexternal covering.
 9. The device according to claim 8, wherein the outercollection layer includes one or more raised ridges or groovespositioned thereon.
 10. The device according to claim 1, wherein thefirst end of the tube extends out from the external covering, andwherein a second end of the tube terminates within the wedge-shapedstructure.
 11. The device according to claim 1, wherein the tube extendsalong a central axis of the fluid collection assembly such that a secondend of the tube extends out from a second end of the fluid collectionassembly.
 12. The device according to claim 1, wherein a second end ofthe tube comprises an adaptor for coupling with a suction device orsuction tubing.
 13. The device according to claim 1, wherein the anchorcomprises a first portion and a second portion separate from the firstportion.
 14. The device according to claim 13, wherein the first portionhas a first width and wherein the second portion has a second width,greater than the first width.
 15. A method for collecting urinedischarged from a body of a user, comprising: providing a urinecollection device, comprising: a fluid collection assembly having afirst end, the fluid collection assembly comprising at least one layerfor drawing urine discharged from the body of the user into an interiorcavity of the urine collection device; an external covering that coversa portion of the at least one layer; at least one fenestration forreceiving urine, wherein the at least one fenestration is a portion ofthe fluid collection assembly that is uncovered by the externalcovering; a tube having a first end in fluid communication with thefirst end of the fluid collection assembly; a wedge-shaped structure atthe first end of the fluid collection assembly, wherein the wedge-shapedstructure has a tapered surface that is configured to fit into glutealfolds and a perineum of the body of the user, wherein the taperedsurface defines an edge at the first end of the fluid collectionassembly, wherein the edge has a length and a width, wherein the lengthis greater than the width, wherein the wedge-shaped structure has afirst end and a second end, wherein the second end of the wedge-shapedstructure is coupled to the first end of the fluid collection assembly,and wherein the first end of the wedge-shaped structure is closed; andan anchor comprising an adhesive layer and extending beyond at least twosides of fluid collection assembly; and positioning the fluid collectionassembly against the body of the user with the at least one fenestrationin operative relation with a urethral opening of the user and adheringthe anchor the user, such that urine discharged from the urethralopening is received by the fluid collection assembly at the at least onefenestration, and then evacuated from the fluid collection assemblythrough the tube.
 16. The method according to claim 15, whereinpositioning the fluid collection assembly against the body of the usercomprises positioning the fluid collection assembly in a verticalorientation with the at least one fenestration in operative relationwith the urethral opening of a female user.
 17. The method according toclaim 15, wherein positioning the fluid collection assembly against thebody of the user comprises positioning the fluid collection assembly ina cup-shaped configuration with the at least one fenestration inoperative relation with a urethral opening of a female user.
 18. Themethod according to claim 15, wherein the wedge-shaped structurecomprises a cap enclosing the first end of the fluid collectionassembly.
 19. The method according to claim 18, further comprisingsecuring the fluid collection assembly to the user by: aligning the capwith the perineum; after aligning the cap with the perineum, positioningthe fenestration between a labia of the body of the user; afterpositioning the fenestration between the labia, bending the anchortoward a pubic region of the user; and after bending the anchor towardthe pubic region, adhering the anchor to the pubic region of the user.20. The method according to claim 15, further comprising: coupling avacuum source to the tube; and applying suction to the tube via thevacuum source to remove urine from the urine collection device.